Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

NCT06577532 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.

Conditions

  • Pancreatic Neoplasms
  • Other Solid Tumors

Interventions

DRUG

ABO2102

mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

DRUG

Toripalimab

Anti-PD-1 antibody, administered intravenously

Sponsors & Collaborators

  • Suzhou Abogen Biosciences Co., Ltd.

    collaborator INDUSTRY
  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Baiyong Shen · Ruijin Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06577532 on ClinicalTrials.gov